Diamedix EBV Test Kit Recalled for Gel-Like Contaminant
Diamedix Corporation is recalling 147 units of the Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit due to a gel-like contaminant that may affect product performance.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Diamedix Corporation is recalling 147 units of the Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit (Catalog No. 720-640) for in vitro diagnostic use. The recall is being conducted because the product contains a gel-like contaminant that may affect product performance.
The affected units are identified by Lot T0006 with an expiration date of 05/31/2018. These products were distributed to facilities in Arizona, California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, and Wisconsin.
This is an FDA Class III recall, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences. Users should stop using the affected test kits and contact Diamedix Corporation for further instructions or a replacement.
The recalled product
- Product
- Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
- Manufacturer
- Diamedix Corporation
- Hazard
- Affected units
- 147
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot T0006 Exp. 05/31/2018
Distribution
Part of a larger recall action
This product is one of 2 recalled by Diamedix Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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